Evaluation of Sublingual Microcirculation Using Sidestream Dark-Field Imaging in Children with Type 1 Diabetes Mellitus with Favorable Treatment Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D
研究概览
简要总结
The main goal of the study is to describe the sublingual microcirculation of children with type 1 diabetes mellitus (T1D) with stable and satisfactory treatment of the disease and to compare it with previously measured parameters of healthy children, NCT05324228.
详细描述
After recording the basic anthropometric parameters, pressure and pulse, each child who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes mellitus
- •informed consent of parents
排除标准
- •acute infection
- •period of metabolic decompensation and 14 days after it
结局指标
主要结局
Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D
时间窗: baseline
Total length of vessels - (no flow + intermittent flow) divided by total surface of area
Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D
时间窗: baseline
Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Total Vascular Density of sublingual microcirculation of children with T1D
时间窗: baseline
Total length of vessels divided by total surface of area
Determination of Small Vessel Density of sublingual microcirculation of children with T1D
时间窗: baseline
Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D
时间窗: baselina
The proportion of perfused vessels (PPV \[%\]) can be calculated as follows: 100 × (total number of vessels - \[no flow + intermittent flow\])/total number of vessels.
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D
时间窗: baseline
The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D
时间窗: baseline
The proportion of perfused small vessels (PPSV \[%\]) can be calculated as follows: 100 × (total number of small vessels - \[no flow + intermittent flow\])/total number of small vessels. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of DeBacker Score of sublingual microcirculation of children
时间窗: baseline
In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines. Higher number means better microcirculation.
次要结局
- Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D(baseline)
- Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation(baseline)
- Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
- Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories(baseline)
研究者
Vlasta Krausová
Principal Investigator
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.